Making Progress in Protecting Consumers from Unsafe Supplements | FDA Voice

Read Dr. Ostroff's (FDA) full comments: Making Progress in Protecting Consumers from Unsafe Supplements | FDA Voice:

"We want to expand our use of criminal investigation and enforcement tools to address serious safety-related violations and cases of intentional fraud; and further build strategic investigatory and enforcement collaborations with the Federal Trade Commission, Department of Justice, and state governments, including state health departments and attorneys general.

Ultimately our top priority is to protect the consumers who want to improve, not damage, their health and have a right to expect that dietary supplements will be safe for them and their families."

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FDA: Janssen Pharma - Pleads Guilty - To Pay Over $1.6 billion - re: Risperdal

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Updated August 29, 2020

The link in the original post broke.

You might also be interested in the DOJ's statement about the issue:

Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists - Justice.gov

- - -  the original post follows below  - - -

Press Announcements > FDA: Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal:

"U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals more than $1.67 billion."

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DOJ - Compliance - Ask Yourself These 5 Questions

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The article below challenges you to think about your people and compliance in the form of 5 questions.

Five Compliance Questions to Ask Yourself, from the DOJ:

"the US Justice Department (DOJ) – in the name of “protecting consumers where they are most vulnerable,” according to Frimpong – is also placing a “focus on people,” since processes and policies (at least publicly-circulated processes and policies) don’t typically break the law; people do. “We know there are enormous cost pressures, but you can’t sacrifice safety under these pressures,” said Frimpong.

To that end, Frimpong recommended that attendees ask themselves five questions about the group of people they work with, to help identify potential problems before they result in an investigation or worse."

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Avoid The DOJ - FCPA Violations - Foreign Corrupt Practices Act

I never heard about the FCPA (Foreign Corrupt Practices Act) until reading about it today. Wikipedia says FCPA addresses accounting transparency requirements under the Securities Exchange Act of 1934 and another concerning bribery of foreign officials.

Anyways, FDANews reports that the Department of Justice’s (DOJ) FCPA and healthcare fraud units are beginning to work together to investigate FCPA violations in the device and pharmaceutical industries. The DOJ has more information about FCPA on their website.

Here's why you need to care. The DOJ wants to aggressively enforce and investigate violations of the FCPA, targeting pharmaceutical and medical device companies as well as their individual executives and board members; this leaves them open to potentially massive legal and financial liabilities.

Additional Resources:
Bribery Abroad: Lessons from the Foreign Corrupt Practices Act

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